Baxter Healthcare Corporation Recall 87013
Description: FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use.
Baxter Healthcare Corporation Recall 87013 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0939-2021 |
| Event ID | 87013 |
| Event Description | FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use. |
| Product Type | Devices |
| Distribution | Distributed nationwide to AZ, FL, OH, NY, GA, VA, MA, WI, MO, MT, WV, IL, NC, NJ, AR, CA, CO, CT, IA, ID, IN, KS, LA, MD, MI, MN, MS, NE, NH, NM, NV, OK, OR, PA, RI, WY, WA, VT, TX, TN, SC, SD |
| Quantity | 109 units |
| Recall Reason | Potential for the battery to lose its ability to be recharged. |
| Device Classification | 20210210 |
| Device Code Info | UDI: 00844735006148; Product Code: 5156-00000-011; Serial Numbers: 135306000279, 135306000280, 135306000281, 135306000282, 135306000283, 135306000284, 135306000286, 135306000287, 135306000288, 135306000289, 135306000290, 135306000291, 135306000292, 135306000293, 135306000294, 135306000295, 135306000298, 135306000299, 135306000300, 135306000301, 135306000303, 135306000304, 135306000305, 135591000306, 135591000307, 136959000309, 136959000310, 136959000311, 136959000312, 136959000313, 136959000314, 136959000315, 136959000316, 136959000317, 136959000318, 136959000319, 136959000320, 136959000321, 136959000322, 136959000323, 136959000324, 136959000325, 136959000326, 136959000327, 136959000328, 136959000329, 136959000330, 136959000331, 136959000332, 136959000333, 136959000334, 136959000335, 136959000336, 136959000337, 136959000338, 136959000339, 136959000340, 136959000341, 136959000342, 136959000344, 136959000345, 136959000346, 136959000347, 136959000348, 136959000349, 136959000350, 136959000351, 136959000352, 136959000353, 136959000354, 136959000355, 136959000357, 136959000358, 136959000359, 136959000360, 136959000361, 136959000362, 136959000364, 136959000365, 136959000366, 137645000392, 137645000393, 137645000394, 137645000395, 137645000396, 137645000397, 137645000399, 137645000400, 137645000401, 139608000552, 139608000555, 139608000571, 139609000583, 139609000589, 139609000596, 139609000597, 139609000598, 139609000599, 139609000600, 139609000601, 139609000602, 139609000603, 139609000604, 139609000605, 139609000606, 139609000607, 139609000608, 139609000609, 139609000610 |
| Center Classification Date | 20210130 |
| Recall Initiation Date | 20201228 |
| Recalling Firm | Baxter Healthcare Corporation |
| Initial Notification | Letter |
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